GlaucomaNCT00742196
Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With the Cirrus High-Definition (HD) Optical Coherence Tomography (OCT)
An observational study of Glaucoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary atrophy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with or without parapapillary atrophy
Who may be able to join
- Qualified OCT images (signal strength > or = 8)
Who cannot join
- Previous intraocular surgery history
- Media opacity
- DM
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gong Je Seong
Seoul, 135-720
Gong Je Seong, MD, PhD, 82-2-2019-3441, gjseong@yuhs.ac
Gong Je Seong, MD, PhD
About this study
Official title: Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With
Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary atrophy.
Read the detailed description
Recently, the retinal nerve fiber layer (RNFL) thickness measurement using the optical coherence tomography (OCT) becomes very useful to detect such a glaucomatous damage. However, there are some difficult cases including parapapillary atrophy to perform this measurement. Because the RNFL thickness is so sensitive to the position of measurement and the measurement of RNFL thickness on parapapillary atrophy is incorrect, it is difficult to determine exact RNFL thickness in patients with a large parapapillary atrophy. In the present study, we want to find the proper method to analyze the RNFL thickness on parapapillary atrophy. The previous OCT used a fixed circle to measure the RNFL thickness, but the new spectral domain OCT, the Cirrus HD OCT, uses a movable one. Therefore, we may suggest a new analysis strategy for the parapapillary atrophy.
- Conditions
- Glaucoma
- Keywords
- Parapapillary atrophy, Retinal nerve fiber layer thickness, Glaucoma, Cirrus OCT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No parapapillary atrophy | |
| 2 | Parapapillary atrophy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fiber layer thickness
Measured: when the OCT images are taking
Size of parapapillary atrophy
Measured: when the OCT images are taking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Gong Je Seong, MD, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742196
- Sponsor's protocol ID
- 3-2008-0076-2
- Status last verified
- Aug 2008
- First submitted
- 26 Aug 2008
- Last updated
- 27 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With
- ClinicalTrials.gov ID
- NCT00742196
- Acronym / sponsor ID
- 3-2008-0076-2
- Conditions
- Glaucoma
- Keywords
- Parapapillary atrophy, Retinal nerve fiber layer thickness, Glaucoma, Cirrus OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary atrophy.
Detailed description
Recently, the retinal nerve fiber layer (RNFL) thickness measurement using the optical coherence tomography (OCT) becomes very useful to detect such a glaucomatous damage. However, there are some difficult cases including parapapillary atrophy to perform this measurement. Because the RNFL thickness is so sensitive to the position of measurement and the measurement of RNFL thickness on parapapillary atrophy is incorrect, it is difficult to determine exact RNFL thickness in patients with a large parapapillary atrophy. In the present study, we want to find the proper method to analyze the RNFL thickness on parapapillary atrophy. The previous OCT used a fixed circle to measure the RNFL thickness, but the new spectral domain OCT, the Cirrus HD OCT, uses a movable one. Therefore, we may suggest a new analysis strategy for the parapapillary atrophy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –No parapapillary atrophy |
| 2 | – | –Parapapillary atrophy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with or without parapapillary atrophy
Key inclusion criteria (1 listed)
- Qualified OCT images (signal strength > or = 8)
Key exclusion criteria (3 listed)
- Previous intraocular surgery history
- Media opacity
- DM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal nerve fiber layer thickness
Time frame: when the OCT images are taking
Size of parapapillary atrophy
Time frame: when the OCT images are taking
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gong Je Seong, MD, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gong Je Seong, MD, PhD (82-2-2019-3441, gjseong@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber layer thickness (time frame: when the OCT images are taking). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2008.